An interventional study of Video capsule investigation in Lynch Syndrome, Li Fraumeni Syndrome and PTEN Hamartoma Syndrome, sponsored by Royal Marsden NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Royal Marsden NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.
The main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.
At recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.
If the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.
Exclusion Criteria:
Device: Video capsule investigation
Participants will undergo both a video capsule examination and a colonoscopy on the same day.
Also known as: Colonoscopy
The proportion of paired images the bioinformatician assesses as useful for the development of algorithm
Time frame: 18 months
The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.
Time frame: 18 months
The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images
Time frame: 18 months
The description of any adverse events collected for the Pillcam procedure.
All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 18 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Colorectal Neoplasms, Hereditary Nonpolyposis→
Royal Marsden NHS Foundation Trust